System for Sensing and Recording Information Regarding Medical Items in a Medical Facility

ABSTRACT

An apparatus tracks medical items through various transition points in a medical facility and maintains a chain of custody for each item through each transition point, indicating who is responsible for each item at any particular time. The apparatus also generates messages directed to various medical facility personnel who are responsible for the medical items at the various transition points, which messages prompt the personnel to take appropriate action with regard to the medical items depending on the particular transition point.

RELATED APPLICATIONS

This application claims priority to U.S. provisional patent applicationSer. Nos. 61/993,578, filed May 15, 2014, titled “System for Sensing andRecording Consumption of Medical Items During Medical Procedure,”62/007,601, filed Jun. 4, 2014, titled “Customer Management of CustomMedical Procedural Trays With E-Commerce Interface,” and 62/048,921,filed Sep. 11, 2014, titled “System for Tracking Medical Items ThroughSupply and Consumption Chain,” and to U.S. nonprovisional patentapplication Ser. No. 14/504,859, filed Oct. 2, 2014, titled “System forSensing and Recording Consumption of Medical Items During MedicalProcedure,” the entire contents of which are incorporated herein byreference.

FIELD

This invention relates to the field of medical item inventorymanagement. More particularly, this invention relates to a system forsensing and recording items that have been consumed during a medicalprocedure.

BACKGROUND

The use of medical supplies and sterile medical devices in the provisionof health care services is one of the most significant expenses incurredby most health care facilities. Depending upon the nature and complexityof the medical procedure being performed, a large number of supply itemsmay be used during a medical procedure and, given the priorities ofmedical personnel involved in the procedure, the ability to track thesupplies, gather data about supply utilization and consumption, andrecord that data in a useable format can be especially difficult. Whilehospitals and other health care facilities may have sophisticatedinformation systems related to supply inventory management andprocedure-based supply requirements, such systems are not able toprovide consistent data analysis of supply utilization and optimizationif the usage data is not recorded diligently.

In a typical hospital, there are multiple different information systemsthat are utilized for managing supply inventory and for insuring thatthe proper supplies are provided for each medical procedure, such as aparticular surgery. In the first instance, the hospital supplydepartment will typically have an inventory management system thattracks medical supply inventory, identifies the location of thatinventory and records inventory levels as supplies are withdrawn forusage or replaced with new shipments of supplies or re-stocks frompreviously withdrawn but unused supplies. This inventory managementsystem typically tracks the location of supplies in multiple locationsthroughout the hospital. In some hospitals, this inventory process isstill a manual process.

Another common type of information system in a typical hospital thatinterfaces with the inventory management system is the Operating RoomInformation System (ORIS). The typical ORIS will provide functionalitysuch as scheduling the operating rooms for procedures, identifying thetype of procedure to be performed, identifying the doctor performing theprocedure, identifying the assisting nurse(s), and maintaining lists ofsupplies, devices and instruments (Bills of Materials, or BOM's) thatshould be provided for each procedure. Typically, these BOM's arespecific to (1) the type of procedure being performed and (2) thephysician performing the procedure. These BOM's are often maintained ina form known as Doctor Preference Cards.

It is common for the hospital inventory management system to interfacewith the ORIS in order to insure that the right supplies, devices andinstruments are in stock and available for the upcoming scheduledmedical procedures. Prior to each case, the BOM for a given procedureand physician is used to pull the appropriate supplies, devices andinstruments for that case.

During the case, supply, device and instrument utilization for theprocedure should be logged and unused items returned to inventory. Whenproperly logged, useful data about supply utilization is captured andcommunicated to both the ORIS system and the inventory managementsystem. That data can subsequently be used to capture cost informationfor the procedure, update the inventory system, prompt necessaryre-orders and, as the data for multiple procedures and physicians isaccumulated, to analyze supply cost and utilization information foroptimization of BOM's to reduce supply waste and identify supply costsavings opportunities.

If accurate information about the consumption of supplies, devices andinstruments is not captured, then the ability to identify savingsopportunities or to accurately bill for all consumed supply items islost. It is difficult to insure that this logging step is performedaccurately and consistently, since the medical personnel are primarilyconcerned with insuring the success of the medical procedure. Often, themedical personnel do not have time during the procedure to manually loginformation into a computer for used items that do not include barcodes,or to scan the barcodes of used items that have barcodes. As a result,much of the information winds up being lost during the turnover of themedical procedure room from one case to another. Another problem withinaccurately recording usage information is the possibility oferroneously charging for items that were not used, which can raiseregulatory issues.

The use of RFID tags as part of the inventory control system haspotential to facilitate the logging of the supply consumption moreaccurately and efficiently.

SUMMARY

In one aspect, embodiments of the invention use Radio FrequencyIdentification (RFID) tags to provide the following general functions:(1) identifying medical items or other resources that enter a room orother space in a medical facility; (2) determining where those medicalitems or other resources came from; and (3) determining whether thosemedical items or other resources were consumed during a medicalprocedure performed in the room or space.

In preferred embodiments of the present invention, each item pulled foruse during a particular medical procedure in accordance with the Bill ofMaterials (BOM) for the procedure and the physician includes an RFID tagaffixed to the item or the item's outer packaging. These RFID tagscontain appropriate inventory information regarding each item asmaintained in the inventory control system and the Operating RoomInformation System (ORIS). Each individual item that might be used canbe tracked through use of the RFID tags and appropriate RFID readertechnology.

In preferred embodiments, each Operating Room (OR) or other procedureroom has a shielded enclosure with multiple RFID antennas disposedinside. Preferably, a waste bin or receptacle is disposed in theshielded enclosure. This shielded enclosure and an RFID reader connectedto the antennas may be conveniently located near the location where thesterile medical supplies are typically opened by the circulating nurseor other OR personnel responsible for setting up the OR for eachprocedure, such as near the OR back table. The RFID reader is preferablyconfigured so as to only sense RFID tags that are inside the enclosureand not to sense RFID tags outside the enclosure.

Some preferred embodiments include a portal containing multiple RFIDantennas connected to an RFID reader for reading RFID tags on medialitems that are passed through the portal. The RFID reader connected tothe portal antennas is preferably configured so as to only sense RFIDtags that are inside the portal and not to sense RFID tags outside theportal. Preferably, the portal is also conveniently located near thelocation where the sterile medical supplies are typically opened by thecirculating nurse or other personnel responsible for setting up the roomfor each procedure. The portal may also be located in areas wheresupplies are stored outside the procedure room and at other transitionlocations in the medical facility.

Once the packaging of a medical supply is opened, that item isconsidered “consumed” because the packaging has been compromised and itcannot be re-stocked. In preferred embodiments, as the packaging ofmedical supply items having RFID tags are opened, the packaging isdropped into the waste bin inside the shielded enclosure and the readerreads the RFID tags on that packaging. The RFID reader is connected to adata collection interface, such as an ORIS computer terminal, a tabletcomputer or smart phone, and the consumption information for each itemis logged.

This system provides an accurate way to track supply utilization thatdoes not require additional data input steps from the OR personnel.Simply throwing the discarded packaging into a waste bin, which isnormal procedure, allows for the RFID tagged supplies to be registeredas consumed.

In a further preferred embodiment, a stock bin is provided. Prior toperformance of a medical procedure, all RFID-tagged medical supply itemsthat were pulled from the supply room or supply cabinet are placed inthe stock bin, the stock bin is moved through the portal or is placedinside the shielded enclosure, and the RFID reader reads the data fromthe RFID tags on the packaging. In this manner, pre-op data regardingitems pulled for use according to a particular BOM can be captured for agiven case.

Following the conclusion of the procedure, all RFID-tagged medicalsupply items that have not been opened, which are thus eligible forre-stocking, are placed into the stock bin, the stock bin is movedthrough the portal or is placed inside the shielded enclosure, and theRFID reader reads the data from the RFID tags on the packaging. In thismanner, post-op data regarding both consumption and non-consumptionrelative to a given BOM can be captured for a given case. In someembodiments, the RFID reader is connected through a data interface intothe ORIS system or the inventory management system and the dataregarding the non-consumed items are captured. The process preferablyassociates medical items (and/or their manufacturer's lot number) andinstrument trays to specific patients in the event of a recall ornegative occurrence that is determined post-case.

Once the pre-op data and post-op data are accurately collected, the datacan be very useful in myriad ways. Since consumption data is accuratelydetermined through the sensing of packaging in the waste bin, billingfor medical items consumed in the case can be more accurately reflectedon the patient's bill, allowing the hospital to more accurately chargefor the procedure. If the stock bin option is included, this ensuresthat items pulled for the procedure that were detected in the pre-opscan, but were not consumed during the procedure are properly returnedto inventory. This process also digitally tracks the movement of eachitem through various transition locations in the medical facility. Thismakes it possible to identify excessive handling of items and potentialexposures to infectious patients.

More sophisticated data analysis can lead to significant costimprovements, such as by trending consumption and non-consumption formultiple procedures and doctors.

Some preferred embodiments provide an apparatus for tracking custody ofmedical items in a supply and consumption chain, wherein each medicalitem has an RFID tag attached thereto that encodes medical iteminformation specific to the medical item. The medical items areinitially collected together as a shipment of medical items, and theshipment has a packing list that has a shipment identifier that encodesshipment identification information specific to the shipment. Theapparatus includes first and second reading devices, first RFIDantennas, a first RFID reader, a medical facility inventory computer,and a medical item inventory database. The first reading device isdisposed in an area of a medical facility at which the shipment of themedical items is received. The first reading device reads the shipmentidentifier associated with the packing list and decodes the shipmentidentification information encoded in the shipment identifier. The firstRFID antennas, which are disposed in a supply room in the medicalfacility, receive first radio frequency signals emanated from the RFIDtags attached to the medical items in the shipment after the medicalitems have been brought into the supply room. The first radio frequencysignals contain the medical item information encoded in the RFID tagsattached to the medical items. The first RFID reader, which isassociated with the supply room of the medical facility and iselectrically connected to the first RFID antennas, decodes the medicalitem information contained in the first radio frequency signals emanatedfrom the RFID tags attached to the medical items. The second readingdevice, which is associated with the supply room of the medicalfacility, reads the shipment identifier associated with the packing listand decodes the shipment identification information encoded in theshipment identifier. The medical facility inventory computer isprogrammed to receive the shipment identification information, themedical item information, a first personnel identifier that identifies aperson responsible for receiving the shipment of medical items at themedical facility, a second personnel identifier that identifies a personresponsible for placement of the medical items into inventory at themedical facility, and a supply room identifier that identifies thesupply room into which the medical items are placed into inventory. Themedical item inventory database associates the shipment identificationinformation with the first personnel identifier, the second personnelidentifier, and the supply room identifier. The medical facilityinventory computer is programmed to automatically generate one or bothof a first message directed to the person responsible for receiving theshipment of medical items at the medical facility and a second messagedirected to the person responsible for placement of the medical itemsinto inventory at the medical facility. The generation of the firstmessage is triggered by the shipment identification information becomingassociated with the first personnel identifier. The second message istriggered by the shipment identification information becoming associatedwith the second personnel identifier. The first and second messagesprompt the person to whom they are directed to take some action withregard to the shipment of medical items.

In some embodiments, the medical item inventory database maintains achain of custody of the medical items in the shipment based oncross-referencing the shipment identification information with the firstpersonnel identifier and the second personnel identifier.

In some embodiments, the apparatus includes a supply room portal havinga portal opening and second RFID antennas having fields of view directedto the portal opening. The second RFID antennas receive second radiofrequency signals emanated from RFID tags attached to medical items thatpass through the portal based on the medical items being picked forremoval from the supply room to be used in a medical procedure. A secondRFID reader that is electrically connected to the second RFID antennasdecodes the medical item information contained in the second radiofrequency signals emanated from the RFID tags. The medical facilityinventory computer is programmed to automatically associate a thirdpersonnel identifier with the medical item information contained in thesecond radio frequency signals, where the third personnel identifieridentifies a person responsible for removal of the medical items fromthe supply room. This association is triggered by the RFID tags on themedical items in the shipment being detected by the second RFID reader.

In some embodiments, the medical item inventory database maintains thechain of custody of the medical items in the shipment based oncross-referencing the medical item information contained in the secondradio frequency signals with the third personnel identifier.

In some embodiments, the apparatus includes a procedure room portalhaving a portal opening and third RFID antennas having fields of viewdirected to the portal opening. The third RFID antennas receive thirdradio frequency signals emanated from RFID tags attached to medicalitems that pass through the procedure room portal when the medical itemsare brought into a medical procedure room to be used in a medicalprocedure. A third RFID reader, which is electrically connected to thethird RFID antennas, decodes the medical item information contained inthe third radio frequency signals emanated from the RFID tags. Themedical facility inventory computer is programmed to automaticallyassociate a fourth personnel identifier with the medical iteminformation contained in the third radio frequency signals, where thefourth personnel identifier identifies a person responsible for themedical items while the medical items are in the medical procedure room.This association is triggered by the RFID tags on the medical items inthe shipment being detected by the third RFID reader.

In some embodiments, the medical item inventory database maintains thechain of custody of the medical items in the shipment based oncross-referencing the medical item information contained in the thirdradio frequency signals with the fourth personnel identifier.

In some embodiments, the apparatus includes a shielded enclosuredisposed in the medical procedure room. The shielded enclosure has aninternal space for receiving wrappers of medical items used during themedical procedure and is configured to attenuate radio frequency signalsemanated from RFID tags disposed outside the shielded enclosure tolevels that are substantially undetectable within the internal space.Fourth RFID antennas are disposed within the internal space of theshielded enclosure. The fourth RFID antennas receive fourth radiofrequency signals emanated from RFID tags attached to the wrappersdisposed within the internal space, which signals contain the medicalitem information encoded in the RFID tags. A fourth RFID reader, whichis electrically connected to the fourth RFID antennas, decodes themedical item information contained in the fourth radio frequency signalsemanated from the RFID tags attached to the wrappers disposed within theinternal space. The medical facility inventory computer is programmed toautomatically associate a patient identifier with the medical iteminformation contained in the fourth radio frequency signals, where thepatient identifier identifies a patient on which the medical procedurewas performed in the medical procedure room. This association istriggered by the RFID tags of the medical items in the shipment beingdetected by the fourth RFID reader.

In some embodiments, the medical item inventory database maintains achain of custody of the medical items in the shipment based oncross-referencing the medical item information contained in the fourthradio frequency signals with the patient identifier.

In some embodiments, the medical facility inventory computer isprogrammed to automatically generate a fifth message directed to patienttreatment personnel if the medical item information indicates that themedical item is a DME item. The generation of the fifth message istriggered by the medical item information contained in the fourth radiofrequency signals becoming associated with the patient identifier. Thefifth message prompts the patient treatment personnel to perform one ormore of the following actions: (1) disclose information to the patientrelated to the proper use of a DME medical item; (2) input informationto verify delivery of a DME medical item to the patient; and (3) obtainthe patient's signature to acknowledge receipt of a DME medical item.

In another aspect, embodiments of the invention provide an apparatus formaintaining an inventory of medical items in a medical facility, whereineach medical item has an RFID tag attached thereto that encodes medicalitem information specific to the medical item. The apparatus includes ashielded enclosure comprising shielded walls, a shielded floor, and ashielded ceiling that collectively define an internal space for storingthe medical items. A shielded door is disposed in one of the shieldedwalls of the shielded enclosure and is operable to allow personnel toenter and exit the internal space. A door lock controller electronicallycontrols a lock on the shielded door. One or more sensors associatedwith the shielded door sense an open state or closed state of theshielded door. One or more storage bins in the internal space hold oneor more medical items. RFID antennas in the internal space receive radiofrequency signals emanated from the RFID tags attached to the medicalitems in the storage bins. The radio frequency signals contain themedical item information encoded in the RFID tags attached to themedical items. An RFID reader, which is electrically connected to theRFID antennas, performs scans to detect RFID tags within range of theRFID antennas and decodes the medical item information contained in theradio frequency signals emanated from detected RFID tags. Preferredembodiments include a computer programmed to discontinue scans by theRFID reader if signals from the one or more sensors associated with theshielded door indicate that the shielded door is in an open state. Thisprevents the RFID reader from detecting RFID tags that are outside theshielded enclosure.

In some embodiments, the computer is programmed to cause the door lockcontroller to maintain the shielded door in a locked state while theRFID reader is performing a scan to detect RFID tags.

In some embodiments, the computer is programmed to control the RFIDreader to perform an RFID system calibration procedure involving a knownnumber of RFID tags attached to medical items disposed in the shieldedenclosure. The procedure includes:

-   (a) performing a scan of the RFID tags with the RFID reader set at a    first transmitter power level;-   (b) the RFID reader detecting a first number of RFID tags attached    to the medical items disposed in the shielded enclosure;-   (c) comparing the first number of RFID tags to the known number of    RFID tags;-   (d) if the first number of RFID tags is less than the known number    of RFID tags, performing a scan of the RFID tags with the RFID    reader set at a second transmitter power level that is incrementally    higher than the first transmitter power level;-   (e) repeating steps (b) through (d) until the first number of RFID    tags equals the known number of RFID tags; and-   (f) operating the RFID reader at the second transmitter power level    for ongoing inventory maintenance purposes.

In some embodiments, the calibration procedure includes:

-   (a) performing a scan of the RFID tags with the RFID reader set at a    first receiver sensitivity level;-   (b) the RFID reader detecting a first number of RFID tags attached    to the medical items disposed in the shielded enclosure;-   (c) comparing the first number of RFID tags to the known number of    RFID tags;-   (d) if the first number of RFID tags is less than the known number    of RFID tags, performing a scan of the RFID tags with the RFID    reader set at a second receiver sensitivity level that is    incrementally higher than the first receiver sensitivity level;-   (e) repeating steps (b) through (d) until the first number of RFID    tags equals the known number of RFID tags; and-   (f) operating the RFID reader at the second receiver sensitivity    level for ongoing inventory maintenance purposes.

BRIEF DESCRIPTION OF THE DRAWINGS

Other embodiments of the invention will become apparent by reference tothe detailed description in conjunction with the figures, whereinelements are not to scale so as to more clearly show the details,wherein like reference numbers indicate like elements throughout theseveral views, and wherein:

FIG. 1 depicts a system for sensing and recording consumption of medicalitems during a medical procedure according to an embodiment of theinvention;

FIGS. 2A and 2B depict shielded enclosures according to embodiments ofthe invention;

FIG. 3 depicts a method for sensing and recording consumption of medicalitems during a medical procedure according to an embodiment of theinvention;

FIG. 4 depicts a method for programming RFID tags for use on medicalitems according to an embodiment of the invention;

FIGS. 5A-5C depict display screens displayed to a user of the systemwhile performing the method depicted in FIG. 4 according to anembodiment of the invention;

FIG. 6 depicts a method for programming RFID tags for use on storagebins used for carrying medical items according to an embodiment of theinvention;

FIGS. 7A-7C depict display screens displayed to a user of the systemwhile performing the method depicted in FIG. 6 according to anembodiment of the invention;

FIG. 8 depicts a method for reading RFID tags on medical items placed inthe shielded enclosure according to an embodiment of the invention;

FIGS. 9A-9C depict display screens displayed to a user of the systemwhile performing the method depicted in FIG. 8 according to anembodiment of the invention;

FIG. 10 depicts a method for reading RFID tags on medical items passedthrough a portal according to an embodiment of the invention;

FIGS. 11A-11B depict display screens displayed to a user of the systemwhile performing the method depicted in FIG. 10 according to anembodiment of the invention;

FIG. 12 depicts a method for searching for medical items having RFIDtags that have been scanned into the system according to an embodimentof the invention;

FIG. 13 depicts a method for searching for medical items and retrievingitem data according to an embodiment of the invention;

FIG. 14 depicts a method for system maintenance according to anembodiment of the invention;

FIG. 15 depicts a display screen displayed to a user of the system whileperforming the method depicted in FIG. 12 according to an embodiment ofthe invention;

FIG. 16 depicts a display screen displayed to a user of the system whileperforming the method depicted in FIG. 13 according to an embodiment ofthe invention;

FIG. 17 depicts a display screen displayed to a user of the system whileperforming the method depicted in FIG. 14 according to an embodiment ofthe invention;

FIGS. 18A-18F depict a portal according to an embodiment of theinvention;

FIGS. 19 and 20 depict processes for sensing and recording utilizationof medical resources in the performance of a medical procedure in amedical facility according to embodiments of the invention;

FIGS. 21 and 22 depict processes for generating alerts based onutilization of medical resources in the performance of a medicalprocedure in a medical facility according to embodiments of theinvention;

FIGS. 23-25 depict a system for tracking medical items through varioustransition points in a supply and consumption chain according to anembodiment of the invention;

FIG. 26 depicts an apparatus for maintaining an inventory of medicalitems according to an embodiment of the invention; and

FIG. 27 depicts a computer system associated with a supply room dooraccording to an embodiment of the invention.

DETAILED DESCRIPTION

As the term is used herein, a “medical item” is an item, material,substance, or piece of durable medical equipment (DME) that is used orconsumed during the performance of a medical procedure or that isdispensed to a patient to treat a medical condition or provide comfortto the patient. For example, sponges, gloves and drapes are medicalitems. A surgical implant is another example of a medical item. Kneebraces, negative pressure wound therapy units, blood glucose monitors,and wheelchairs are further examples of medical items. Medical itemscomprise a subset of “medical resources.” As the term is used herein, a“medical resource” is any item, person, piece of equipment, or spaceinvolved in providing medical services for a patient. For example, agurney on which a patient lies during a surgical procedure is a medicalresource. The doctor performing the procedure, the attending nurses, andthe patient are also medical resources. An operating room is a medicalresource.

As the term is used herein, a “wrapper” encompasses all manner ofcontainers and packaging, sterile or non-sterile, in which a medicalitem is or has been enclosed. The term “wrapper” also includes a label,hang tag, or other such device that may be attached to a medical itemwithout completely enclosing the item. The term “wrapper” furtherincludes packaging for a sterile-wrapped kit of medical items, such as atray of implants and supplies for use in a surgical procedure, whereinan RFID tag is attached to the tray. Generally, anything that mayfunction to associate an RFID tag with a medical item is encompassed bythe term “wrapper.”

Each medical item has a unique item identifier encoded in amachine-readable code in an RFID tag, a QR code, a bar code, or acombination thereof attached to the medical item or its wrapper. In someembodiments, an RFID tag and a QR code are combined in a single labelapplied to the medical item or its wrapper.

In a preferred embodiment, each wrapper includes an RFID tag attachedthereto or embedded therein. Ultra High Frequency (UHF) passive RFIDtags are preferred for this application, as they may be interrogatedfrom up to about 30 centimeters away. In preferred embodiments, eachRFID tag is encoded with a unique item identification number for theparticular medical item associated with the wrapper. An item informationdatabase 52 associates each item identification number withitem-specific information, such as the manufacturer part number, itemdescription, vendor, cost, Latex content, expiration date, and inventorylocation. Additionally or alternatively, the RFID tag may be encodedwith item-specific information as set forth in Unique DeviceIdentification (UDI) standards set by the U.S. Food and DrugAdministration (FDA).

In some embodiments, item-specific information encoded in RFID tags onmedical items may be used to generate alerts for medical personnel. Forexample, an alert may be generated if information encoded in an RFID tagindicates the presence of Latex in an item, and the patient is allergicto Latex. Also, an alert may be generated if information encoded in anRFID tag indicates that an item's useful lifetime has expired or if theitem is from a lot that has been recalled by the manufacturer.

As the term is used herein, a “portal” is any passageway, opening,aperture, window, panel, wall, doorway, hallway, pathway, or aisle in ornear which one or more RFID antennas are mounted for sensing RFID tagsthat pass through or near the portal. A portal may also be a handheldscanning device for reading RFID tags. Several portals may be used totrack the routes of travel and locations of medical resources throughouta medical facility or a medical item supplier facility.

As the term is used herein, a “scan” for RFID tags refers to operationsperformed by an RFID reader to transmit signals and receive signals fromRFID tags that are in range of the RFID reader and its associatedantenna(s).

In preferred embodiments, portals are placed at “transition locations”within a medical facility or a medical item supplier facility. Examplesof transition locations include supply rooms, supply cabinets, procedurerooms, waste containers, personnel break rooms, hallways, shipmentassembly areas, shipment loading docks, and points of entry into andexit from the medical facility or a medical item supplier facility.

As the term is used herein, a “shipment” of medical items comprisesmultiple medical items, of the same type or different types, that arepackaged together at a supplier location and shipped to a location atwhich the medical items are consumed or dispensed. Generally, eachshipment includes a packing list that lists all of the medical items inthe shipment. In preferred embodiments, each packing list has a uniqueshipment identifier that encodes shipment identification informationthat is specific to the shipment. The shipment identifier may be in theform of an RFID tag, bar code, or other encoded identifier attached to,embedded in, or printed on the packing list.

Sensing and Logging Consumption of Medical Items During MedicalProcedure

As shown in FIG. 1, a system 10 for sensing and logging consumption ofmedical items during a medical procedure includes a shielded enclosure12 having a space 16 that is large enough to receive a waste bin 18.Disposed within the enclosure 12 are two RFID antennas 14 a and 14 b,such as Laird 5×5 inch Mini Far Field antennas (model number S9025PLNF)having left-hand circular polarization and operating in the 902-928 MHzfrequency range. One of the antennas 14 a is preferably disposed at thetop of the enclosure 12, with its field of view looking downward intothe space 16. The other RFID antenna 14 b is preferably disposed at thebottom of the enclosure 12, with its field of view looking upward intothe space 16. The RFID antennas 14 a-14 b are electrically connected,such as via a coaxial cable, to a UHF RFID tag reader 28. In a preferredembodiment, the RFID tag reader 28 is an Impinj® Speedway® model R420.

Preferred embodiments of the shielded enclosure 12 are shown in FIGS. 2Aand 2B, wherein the sidewalls are depicted as transparent. The enclosure12 is preferably made from 0.080 inch thick sheet aluminum supported by0.75×0.75 inch square aluminum tubing (0.125 thick). The outsidedimensions of the preferred embodiment are 23.5×22.0×40.75 inches.

As the term is used herein, “shielded” means that the enclosure 12 isdesigned to prevent the antennas 14 a-14 b from receiving RFID signalsfrom RFID tags located outside the enclosure 12 at a signal-to-noiseratio high enough to trigger detection of those outside RFID tags. Forpurposes of this disclosure, “shielded” does not mean that absolutelyall RF energy is blocked from entering the enclosure, as this wouldrequire unnecessary levels of shielding.

In some embodiments, an opening 24 is provided in the top of theenclosure that is large enough to receive wrappers or containers 20 fromwhich medical items have been removed. The opening 24 is preferably a6.75×13.75 inch rectangle. An aluminum cover 25 is provided over theopening 24. The cover may be slanted as shown in FIG. 2A or morebox-like as shown in FIG. 2B to prevent signals from escaping theenclosure 12. As shown in FIG. 2B, the enclosure preferably includes analuminum chute 23 around the opening 24, and an aluminum shield 27around the antenna 14 a. These structures provide further attenuation ofRFID signals originating outside the enclosure 12 to prevent thosesignals from being detected by the antennas 14 a-14 b. The waste bin 18is positioned below the opening 24 so that wrappers 20 deposited in theopening 24 fall into the bin 18. In a preferred embodiment, a hingeddoor 26 large enough to receive the waste bin 18 is provided in asidewall of the enclosure 12. The door 26 is preferably 29.5×39.25 inch,and includes a handle/latch for securing the door in a closed position.The enclosure 12 is considered to be shielded when the door 26 isclosed.

In a preferred embodiment, the system 10 includes a portal 48 having anopening 49 at least large enough to receive the waste bin 18. The portal48 is preferably equipped with four RFID antennas 50 a-50 d havingfields of view looking inward into the portal opening 49. The RFIDantennas 50 a-50 d are electrically connected, such as via coaxialcables, to a UHF RFID tag reader 46. In a preferred embodiment, the RFIDtag reader 46 is an Impinj® Speedway® model 8220. In some embodiments,the tag reader 46 and the tag reader 28 comprise a single tag reader.

The waste bin 18, also referred to herein as a waste tote, is preferablya plastic container having an open top for receiving wrappers 20. Insome embodiments, an RFID tag 22 encoded with a unique binidentification number is attached to the waste bin 18. The database 52associates the bin identification number with a particular procedureroom to which the waste bin 18 is assigned. Alternatively, the RFID tag22 may be encoded with information indicating the procedure room towhich the bin 18 is assigned.

The RFID tag readers 28 and 46 are electrically connected via a localarea network (LAN) 42 to a medical item inventory computer 31, which maybe a server computer, desktop computer, laptop computer, tablet computeror other mobile computing device. Alternatively, the electricalconnection between the RFID tag readers 28 and 46 and the computer 31 isvia a Universal Serial Bus (USB) interface. The computer 31 includesmemory for storing and a processor for executing instructions of amedical item inventory module 40. In preferred embodiments, the medicalitem inventory module 40 compiles pre-op and post-op lists of items,compares the lists to detect discrepancies, generates alert messagesupon detection of discrepancies, and updates inventory records based onactual item usage.

In a preferred embodiment, an Operating Room Information System (ORIS)computer 30 is in communication with the medical item inventory computer31 via a communication network, such as the LAN 42. The ORIS computer 30is also in communication with a hospital computer system 32 via acommunication network, such as the LAN 42. In preferred embodiments, thehospital computer system 32 manages medical item inventories, operatingroom scheduling, patient records, insurance reimbursement/paymentfunctions, and admission/discharge/transfer (ADT) records. The hospitalcomputer system 32 may also include or be connected to an electronicdata interchange server, such as a J.D. Edwards/Oracle server, thatimplements electronic commerce transactions between the hospital andmedical item suppliers.

In some embodiments, the medical item inventory module 40 is a softwareapplication running on the computer 31. In alternative embodiments, themedical item inventory module 40 is executed by a remote computer(outside the OR). For example, the medical item inventory module 40 maybe implemented as “software-as-a-service” provided via the Internet by amedical item inventory service provider.

With continued reference to FIG. 1, a preferred embodiment of the system10 includes a stock bin 34, which may also be referred to herein as atransport bin or stock tote. As described in more detail below, thestock bin 34 is used to transfer medical items 38 to be used during amedical procedure from a stock room to the procedure room, and totransfer unused medical items 38 from the procedure room back to thestock room. In some embodiments, an RFID tag 36 is attached to the stockbin 34 that is encoded with a unique bin identification number. In someembodiments, the database 52 associates the bin identification numberwith a particular procedure room or stock room to which the stock bin 34is assigned. Alternatively, the RFID tag 36 may be encoded withinformation indicating the procedure room or stock room to which thestock bin 34 is assigned.

FIG. 3 depicts a preferred embodiment of a process 100 for sensing andrecording consumption of medical items during a medical procedure usingthe system depicted in FIG. 1. To begin the process, hospital personnelpick medical items from inventory stock to be used during the medicalprocedure (step 102 in FIG. 3). For example, the needed items may belisted on a Bill of Materials (BOM) for the particular type of procedureto be performed. In some cases, the BOM also reflects the individualpreferences of particular doctors. These types of BOM's may also bereferred to as Doctor Preference Cards. The picked items are placed inthe stock bin 34 to be transferred to the OR.

In one embodiment, the stock bin 34 containing the picked items 38 isplaced in or passed through the portal 48 outside the procedure room(step 104) and the RFID reader 46 reads the RFID tags on the wrappers ofthe items 38 in the stock bin 34 (step 106). In some embodiments,activation of the reader 28 is triggered manually by a person in theprocedure room using an interface device (mouse, touchpad or keyboard)of the computer 31.

The item identification numbers read from the RFID tags in the portal 48are transferred to the medical item inventory computer 31 where themedical item inventory module 40 compiles a pre-op list of the items 38in the stock bin 34 (step 108). In a preferred embodiment, the date/timeof the compilation of the list is recorded in the medical item inventorycomputer 31, along with the identification number of the stock bin 34.Other information may be associated with the pre-op list, such asprocedure room number, doctor name, patient name, patient age, patientweight, patient allergies, type of medical procedure, and case number.Once the pre-op list is compiled, the RFID reader 28 may be deactivated(step 109) and the stock bin 34 removed from the portal 48 (step 110).

Steps 104-110 of FIG. 3 are optional and are not implemented in allembodiments of process 100. If these steps are not performed, the BOMfor the medical procedure may serve the purpose of the pre-op item list.

The items 38 are preferably removed from the bin 34 and arranged on atable in the procedure room according to the doctor's or attendingnurse's preference. As the items 38 are used/consumed during theprocedure (step 112), wrappers 20 removed from the items 38 are droppedthrough the opening 24 in the enclosure 12 where they are received intothe waste bin 18 (step 114). When the wrappers 20 enter the enclosure12, the RFID tags on the wrappers 20 are detected and read by the reader28 (step 116). It will be appreciated that a waste bin 18 is notabsolutely necessary for this process. However, the use of a waste bin18 makes collection and removal of the wrappers 20 easier.

The item identification numbers read from the RFID tags in the enclosure12 are transferred to the medical item inventory computer 31 where themedical item inventory module 40 compiles a post-op used-item list ofthe wrappers 20 (step 118). In a preferred embodiment, the date/timethat each wrapper 20 was first detected is recorded in the list. Also,the identification number of the waste bin 18 (if any) and otherinformation may be associated with the post-op used-item list, such asprocedure room number, doctor name, patient name, type of medicalprocedure, and case number. Once the post-op used-item list is compiled,the RFID reader 28 is deactivated (step 119) so that it will not readany other tags when the door 26 is opened to remove the wrappers 20(step 120). Deactivation of the reader 28 may be triggered by openingthe door 26 of the enclosure 12.

In an alternative embodiment, the waste bin 18 remains outside theshielded enclosure 12 during the procedure. As the items 38 areused/consumed during the procedure (step 112), wrappers 20 removed fromthe items 38 are deposited in the waste bin 18. After completion of theprocedure, the waste bin 18 containing the wrappers 20 is placed throughthe portal 48 (step 114), and the reader 28 reads the RFID tags of thewrappers 20 (step 116). The post-op used-item list is compiled asdescribed in the previous embodiment (step 118).

In some embodiments, after completion of the medical procedure, allunused items 38 are placed back into the stock bin 34, and the stock bin34 is passed through the portal 48 (step 122). The reader 46 reads theRFID tags of the unused items 38 (step 124), and a post-op unused-itemlist is compiled (step 126). The identification number of the stock bin34 and other information may be associated with the post-op unused-itemlist, such as procedure room number, doctor name, patient name, type ofmedical procedure, and case number.

Steps 122-126 of FIG. 3 are optional and are not implemented in allembodiments of process 100. If these steps are not performed, thepost-op unused-item list may be generated by comparing the BOM to thepost-op used item list.

Various embodiments of the invention use the pre-op and post-op itemlists to implement various advantageous inventory and billing functions.For example, the medical item inventory module 40 may compare the itemslisted in the pre-op list to the items listed in the post-op used-itemlist and the post-op unused-item list (step 128). If an item in thepre-op list does not appear on either of the post-op lists (step 130),this means the item was brought into the procedure room but neither theitem nor its wrapper ended up in the stock bin or the waste bin afterthe procedure. In this case, an alert is generated that causes a messageto appear on a display screen of the ORIS computer 30 or the medicalitem inventory computer 31 (step 132). The alert should prompt theprocedure room personnel to investigate three possibilities that mayhave caused the discrepancy: (1) the item is unused and still in theprocedure room but was inadvertently not placed back into the stock binbefore the post-op unused-item list was compiled, (2) the item was usedand its wrapper is still in the procedure room but the wrapper wasinadvertently not placed in the waste bin before the post-op used-itemlist was compiled, or (3) the item and/or its empty wrapper was removedfrom the procedure room prior to compilation of either of the post-oplists. In any event, the missing item(s) or wrapper(s) should be locatedand the pre-op and post-op lists reconciled (step 134).

If the comparison of the pre-op and post-op item lists indicates that anitem that appears on either of the post-op lists is not on the pre-oplist (step 136), this means that the item or its wrapper was present inthe procedure room when the post-op lists were compiled, but it was (1)not brought into the procedure room in the stock bin with the otheritems, or (2) brought into the procedure room in the stock bin but wasremoved from the stock bin prior to compilation of the pre-op list. Inthis case, an alert is generated which causes a message to appear on adisplay screen of the computer 31 (step 138). The alert should promptthe procedure room personnel to investigate what may have caused thediscrepancy and reconcile the pre-op and post-op lists (step 140).

In a preferred embodiment, once the post-op lists are complete andreconciled, the computer 31, the ORIS computer 30, or the hospitalcomputer system 32 uses the lists to update the database 52 based onactual item usage (step 142). The hospital computer system 32 or theORIS computer 30 also may use the post-op used-item list to accuratelybill the patient (or insurance company) for the items used during theprocedure (step 146). The stock bin 34 may be returned to theappropriate inventory stock room where the unused items 38 may bereturned to inventory (step 144).

In preferred embodiments, the hospital computer system 32 or the MedicalItem Inventory Application 40 analyzes the post-op unused-item listsgenerated during multiple procedures of the same type and for the samedoctor to determine trends in the lack of usage of certain medical itemsthat are listed on BOM's (step 146). This trend data may be used torevise the BOM's for certain procedures/doctors. For example, if thetrend data indicates that in 90% of hip replacement surgeries performedby Dr. Jones only three sponges of a particular type are used out of thefive called for on the BOM, the BOM may be revised to call for onlythree sponges. Revisions of this sort would reduce the effort/costassociated with returning unused items to the stock room, and woulddecrease traffic in and out of the procedure room during a procedurewhich would decrease the chances of a site infection. Trend data mayalso be used to determine the optimal locations to store medicalsupplies and the optimal quantities to store.

FIG. 4 depicts an embodiment of a method 150 for programming RFID tagsfor medical items. While running the medical item inventory application,the user selects the “Program Tags” tab on the example display screendepicted in FIG. 5A (step 152). If the user does not know the itemnumber of the medical item for which a tag is to be programmed (step154), the user may select the “Search” button (step 156). This causesthe application to display an items list (step 158) from which the userselects the item (step 160). The user then enters the lot number andexpiration date (step 162) and selects the “Query Available Tags” button(step 166). This activates the RFID reader/writer to detect and displaya number of tags that are available for programming (step 168). In theexample of FIG. 5B, the RFID reader/writer detected fifteen tagsavailable for programming. Before programming the tags with iteminformation, the user has an opportunity to edit the item information(step 170). If the item information is complete and accurate, the userselects the “Confirm and Program” button (step 172). This causes theRFID reader/writer to program the available RFID tags with the iteminformation (step 174). The number of tags that are successfullyprogrammed are indicated as “Number of Successful Writes” as shown inFIG. 5C (step 176). The user then selects the “Continue” button (step178), which causes the application to associate the newly programmedtags with the item number in the database 52 (step 180).

FIG. 6 depicts an embodiment of a method 190 for programming RFID tagsfor bins or totes, such as the waste bin 18 or the storage bin 34. Whilerunning the medical item inventory application, the user selects the“Program Totes” tab on the example display screen depicted in FIG. 6A(step 192). The user then enters the item number for the tote (step 194)and selects the “Query Available Tags” button (step 196). This activatesthe RFID reader/writer to detect the number of tags that are availablefor programming (step 198) and display the available number on thedisplay device (step 200). In the example of FIG. 7B, the RFIDreader/writer detected three tags available for programming. If the userwishes to proceed with the programming process, the user selects the“Confirm and Program” button (step 204). This causes the RFIDreader/writer to program the available RFID tags with the toteinformation (step 206). The number of tags that are successfullyprogrammed are indicated as “Number of Successful Writes” as shown inFIG. 7C (step 176). The user then selects the “Continue” button (step208), which causes the application to associate the newly programmedtags with non-consumable totes in the database 52 (step 210). Theprogrammed tags are then attached to the totes (step 212).

FIG. 8 depicts an embodiment of a method 220 for reading RFID tags onitems dropped into the shielded enclosure 12. While running the medicalitem inventory application, the user selects the “Dynamic Scan” tab onthe example display screen depicted in FIG. 9A and selects the scantype, such as “Intra-Op” from the dropdown list (step 222). When theuser selects the “Begin Scan” button (step 224), the RFID tag reader 28is activated and begins reading the tags of any items or item wrappersdropped into the enclosure 12 (step 226). As shown in FIG. 9B,information regarding all tagged items detected by the RFID tag readeris displayed on the display device (step 228). In this example, threetagged items or item wrappers were detected: (1) item 5-2711 ScalpelStainless . . . , (2) item TOTE, and (3) item 712542 Drape Hand 114× . .. . If at some point during the medical procedure the waste bin withinthe enclosure needs to be emptied, the user selects the “Pause Scan”button in FIG. 9B (step 232), which causes the application to stop theRFID tag reader and display “Paused” on the screen as shown in FIG. 9C(step 234). After the full bin has been replaced with an empty bin inthe enclosure (step 236), the user selects the “Continue” button (step238), which causes the RFID tag reader 28 to resume reading the tags ofany additional items or item wrappers dropped into the enclosure 12(step 226). When the medical procedure is complete and no more wrappersare to be dropped into the enclosure 12 (step 240), the user selects the“Stop Scan” button (step 242), which causes the RFID tag reader 28 tocease detecting RFID tags in the enclosure (step 246). The user thenselects the “Write Scans” button (step 250) at which point theapplication stores in the database 52 all the item information regardingitems or item wrappers that were placed into the enclosure during themedical procedure (step 252).

FIG. 10 depicts an embodiment of a method 260 for reading RFID tags onitems passed through the portal 48. While running the medical iteminventory application, the user selects the “Static Scan” tab (step 262)on the example display screen depicted in FIG. 11A and selects the scantype, such as “OR Pre-Op” from the dropdown list (step 264). The userthen enters the case number for the medical procedure (step 266) andselects the “Scan” button (step 268). The application then activates theRFID tag reader 28, which begins reading the tags of any items or itemwrappers within the field of view the antennas in the portal opening 49(step 270). When the user pushes a tote containing RFID-tagged itemsthrough the portal opening 49 (step 272), the RFID tag reader 46 readsthe tags of the items in the tote and the application displays a list ofthe items on the display device as shown in FIG. 11B (step 274). Theuser then selects the “Write Scans” button (step 278) at which point theapplication stores in the database 52 all the item information regardingitems that were passed through the portal (step 280).

FIG. 12 depicts an embodiment of a method 290 for viewing listings ofitems whose RFID tags have been read and entered into the database 52.While running the medical item inventory application, the user selectsthe “View Scans” tab (step 292) on the example display screen asdepicted in FIG. 15 and chooses to search by item, by case number or byElectronic Product Code (EPC) (step 294). As will be appreciated by oneskilled in the art, the EPC is a unique number that identifies aspecific item in the supply chain. When the user enters the searchcriteria (such as CASE123) in the text box (step 296) and selects the“Search” button (step 298), the application retrieves item informationfrom the database 52 regarding all items scanned in association withCASE123 and displays a list of the item information on the displaydevice as shown in FIG. 15 (step 300).

FIG. 13 depicts an embodiment of a method 310 for viewing listings ofitems having information stored the database 52. While running themedical item inventory application, the user selects the “Items” tab(step 312) on the example display screen as depicted in FIG. 16 andenters an item number or item keywords in the search text box (step314). When the user selects the “Search” button (step 316), theapplication retrieves item information regarding all items in thedatabase 52 and displays a list of the item information on the displaydevice as shown in FIG. 16 (step 318). If the list indicates that RFIDtags have not yet been programmed for an item (step 320), the user mayselect the “Program” button (step 322) which will cause the applicationto display the “Program Tags” tab (step 324).

FIG. 14 depicts an embodiment of a method 330 for performing maintenancetasks related to the database 52 and the LAN 42. While running themedical item inventory application, the user selects the “Maintenance”tab (step 332) on the example display screen as depicted in FIG. 17 andenters the network address of the database 52 (step 334). The user maythen select the “Test” button to test the connection to the database 52(step 336). If the test indicates a successful connection, the user mayselect the “Save” button to store the database address information (step340). The “Maintenance” tab also allows the user to test the networkconnection to the RFID tag reader(s) by entering the IP address in theaddress box (step 342) and selecting the “Test” button (step 344). Ifthe test indicates a successful connection, the user may select the“Save” button to store the IP address information (step 348).

Tracking Utilization of Medical Resources in Medical Facility

Various embodiments described herein provide systems for sensing RFIDtags attached to various medical resources at various transitionlocations throughout a medical facility, for tracking routes of movementof the medical resources based on the sensing of the RFID tags, fordetecting relationships between medical resources based on sensing theirRFID tags at the same transition locations during overlapping timeperiods, for analyzing utilization of the medical resources, and fordeveloping utilization profiles. For example, FIG. 19 depicts anembodiment of a process 400 for analyzing the utilization of twodifferent medical resources based on sensing (or not sensing) their RFIDtags at two different transition locations within a medical facility.The process 400 involves attaching RFID tags to medical resources (step402), disposing RFID-sensing portals at various transition locationswithin the medical facility (step 404), reading medical resourceinformation from the RFID tags using the portals (step 406 and 412), anddecoding the medical resource information to identify the medicalresources (step 408 and 414) and determine various characteristics ofthe resources as described in more detail below.

For example, with continued reference to FIG. 19, a first medicalresource is detected at a first transition location at a time T1 (step410) and at a second transition location at a time T2 (step 416). Basedon these detections, the system determines that the first medicalresource travelled from the first transition location to the secondtransition location between times T1 and T2 (step 418). Based on thisroute of travel and the times of detection, the system creates autilization profile for the first medical resource (step 420).

A second medical resource is detected at the first transition locationat a time T3 (step 422), which may be less than, greater than, or equalto time T1. The second medical resource is again detected at the firsttransition location at a time T4 (step 426), which is occurs after timeT3 (T4>T3). There is no detection of the second medical resource at thesecond transition location between times T3 and T4 (step 424). Based onthese detections, the system determines that the second medical resourcetravelled from the first transition location back to the firsttransition location between times T3 and T4, and did not travel to thesecond transition location (step 428). Based on this route of travel andthe times of detection, the system creates a utilization profile for thesecond medical resource (step 430).

In the example of FIG. 19, the first transition location may be anentrance/exit door of a medical procedure room PR1 within a medicalfacility, the second transition location may be a waste container WC1within the medical procedure room PR1, the first medical resource may bea first medical item that was picked to be used during a medicalprocedure MP1 in the procedure room PR1, and the second medical resourcemay be a second medical item that was picked to be used during the samemedical procedure MP1 in the procedure room PR1. Based on the detectionsdescribed above, the system determines that the first medical itementered the medical procedure room PR1 (first transition location) attime T1, and it or its wrapper was deposited in the waste container WC1(second transition location) at time T2. Based on this route of travel,the system creates a utilization profile indicating that the firstmedical item was used or consumed during the medical procedure MP1. Alsobased on the detections described above, the system determines that thesecond medical item entered the medical procedure room PR1 (firsttransition location) at time T3, exited the medical procedure room PR1(first transition location) at time T4, and was not deposited in thewaste container WC1 (second transition location). Based on this route oftravel, the system creates a utilization profile indicating that thesecond medical item was brought into the medical procedure room PR1, butwas not used during the medical procedure MP1.

FIG. 20 depicts an embodiment of a process 440 for analyzing theutilization of three different medical resources based on their RFIDtags being sensed (or not sensed) at two different transition locationswithin a medical facility. The process 440 involves reading medicalresource information from RFID tags attached to three medicalresources—a first medical item, a doctor, and a patient—using portals atthe entrance/exit of a procedure room PR1 and on a waste container WC1(step 442 and 448), and decoding the medical resource information toidentify the medical resources (step 444 and 450) and determine variouscharacteristics of the resources. As in the previous example, the systemdetermines that the first medical item entered the medical procedureroom PR1 at time T1, and it or its wrapper was deposited in the wastecontainer WC1 at time T2 (step 454). Based on this route of travel, thesystem creates a utilization profile indicating that the first medicalitem was used during the medical procedure MP1 (step 456).

With continued reference to FIG. 20, the system detects the doctor D1entering the medical procedure room PR1 at time T3 which may be lessthan, greater than, or equal to time T1 (step 458). The doctor D1 isdetected leaving the medical procedure room PR1 at time T4 which isgreater than T1 and T3 (step 460). Based on this route of travel, thesystem creates a utilization profile indicating that the doctor D1 wasinvolved in a medical procedure MP1 in the procedure room PR1 betweentimes T3 and T4 (step 464). In preferred embodiments, the utilizationprofile for the doctor D1 indicates that the first medical item wasconsumed or used during a medical procedure MP1 performed by the doctorD1. In some embodiments, the utilization profile for the first medicalitem also indicates that the first medical item was consumed or usedduring a medical procedure MP1 performed by the particular doctor D1.

With continued reference to FIG. 20, the system detects the patient P1entering the medical procedure room PR1 at time T5 which may be lessthan, greater than, or equal to time T1 (step 466). The patient P1 isdetected leaving the medical procedure room PR1 at time T6 that isgreater than T1 and T5 (step 468). Based on this route of travel, thesystem creates a utilization profile indicating that the patient P1 wasinvolved in a medical procedure MP1 in the procedure room PR1 betweentimes T5 and T6 (step 470). In preferred embodiments, the utilizationprofile for the patient P1 also indicates that the first medical itemwas consumed or used during the medical procedure MP1 performed on thepatient P1 by the particular doctor D1. In some embodiments, theutilization profile for the first medical item also indicates that thefirst medical item was consumed or used during the medical procedure MP1performed on the particular patient P1. In some embodiments, theutilization profile for the doctor D1 also indicates that the firstmedical item was consumed or used during the medical procedure MP1performed on the particular patient P1.

Generating Alerts Based on Utilization of Medical Resources in MedicalFacility

FIG. 21 depicts a preferred embodiment of a process 480 for generatingan alert based on utilization of medical resources in the performance ofa medical procedure in a medical facility. This process 480 analyzes theutilization of two different medical resources based on sensing theirRFID tags at the same transition location within the medical facility.The process 480 involves reading medical resource information from RFIDtags attached to the two medical resources—a first medical item and apatient P1—using portals at the entrance/exit of a procedure room PR1(step 482), and decoding the medical resource information to identifythe medical resources (step 484) and to determine variouscharacteristics of the resources. For example, the medical resourceinformation decoded at step 484 may indicate whether the first medicalitem contains a potential allergenic, such as Latex, and whether thepatient P1 is allergic to any drugs or substances, such as Latex. Usingthe decoded information, the system detects that the first medical itementered the medical procedure room PR1 (step 486) at a certain time andthat the patient P1 entered the medical procedure room PR1 at a certaintime (step 492). If the first medical item contains a substance to whichthe patient P1 is allergic, and the first medical item and the patientP1 are in the procedure room PR1 simultaneously (steps 488, 494 and496), the system generates an alert informing personnel in the procedureroom PR1 of the potential for a harmful allergic reaction (step 498).This alert may be audible (siren) and visible (strobe lights) in theprocedure room, and it may be sent via electronic messaging to otherpersonnel within the medical facility to give notice of the situation.In preferred embodiments, the occurrence of such an event is alsoreflected in the utilization profile of the patient P1.

In some embodiments, the system generates a potential allergic reactionalert if an RFID reader portal at the doorway of a supply room detects amedical item leaving the supply room that was picked for use during amedical procedure involving a patient that is allergic to a substance inthe medical item. This detection could also be made by any RFID readerportal at any transition location between the supply room and themedical procedure room.

FIG. 22 depicts a preferred embodiment of another process 500 forgenerating an alert based on utilization of medical resources in theperformance of a medical procedure in a medical facility. This process500 analyzes the utilization of two different medical resources based onsensing their RFID tags at the same transition location within themedical facility. The process 500 involves reading medical resourceinformation from RFID tags attached to the two medical resources—a firstmedical item and a patient P1—using portals at the entrance/exit of aprocedure room PR1 (step 502), and decoding the medical resourceinformation to identify the medical resources (step 504) and todetermine various characteristics of the resources. For example, themedical resource information decoded at step 504 may indicate that thepatient P1 is infected with a highly infectious contagion, such asMethicillin-resistant Staphylococcus aureus (MRSA). Using the decodedinformation, the system detects that the first medical item entered themedical procedure room PR1 (step 506) at time T1 and that the patient P1entered the medical procedure room PR1 at a certain time (step 514). Thesystem later detects that the first medical item has exited the medicalprocedure room PR1 (step 508) at time T2. If the first medical item wasnot deposited in a hazardous waste container prior to leaving theprocedure room PR1, and the first medical item and the patient P1 werein the procedure room PR1 simultaneously, and the patient P1 is infectedwith a contagion such as MRSA (steps 510, 516, 518), the systemgenerates an alert informing personnel in the procedure room PR1 of apotential for spread of a highly infectious contagion due to possiblecontact with the first medical item (step 520). This alert may beaudible (siren) and visible (strobe lights) in the procedure room, andit may be sent via electronic messaging to other personnel within themedical facility to give notice of the situation. In preferredembodiments, the occurrence of such an event is also reflected in theutilization profile of the first medical item. In some situations, thedetermination that the patient is infected (step 516) may be made afterthe procedure is complete and the patient has left the procedure room.In such situations, the system will generate the alert (step 520) afterinformation indicating the patient's infection is entered into thepatient's record (the medical resource information for the patient.)

Tracking Custody of Medical Items in Supply and Consumption Chain

FIGS. 23-25 depict a system for tracking medical items through varioustransition points in a supply and consumption chain. As shown in FIG.23, each shipment 54 of medical items 38 includes a packing list 56 thathas a unique shipment identifier 58 encoded in an RFID tag and/or a barcode attached to the packing list. Upon packing of medical items 38 at asupplier facility for shipment (first transition point), a unique itemidentifier 39 encoded in an RFID tag and/or a bar code attached to eachpacked medical item 38 and the unique shipment identifier 58 of theaccompanying packing list 56 are read by one or more reading devices 59and are cross-referenced in a supplier inventory database 60. Inpreferred embodiments, the reading devices 59 may include one or moreRFID tag readers and their associated antennas and one or more bar codereaders. The one or more reading devices 59 may also read the uniquepersonnel identifier 55 of the person responsible for the shipment ofmedical items at the supplier facility, which identifier may be encodedin the person's ID badge 57. In a preferred embodiment, the uniqueshipment identifier 58 is also cross-referenced in the supplierinventory database 60 with the unique personnel identifier 55. As theterm is used herein, a “supplier facility” is any location at which themedical items are disposed prior to shipment to the medical facility,such as a manufacturer facility or a distributor facility.

Upon receipt of the shipment 54 of medical items at the medical facility(second transition point), the unique shipment identifier 58 of thepacking list 56 is read and decoded by one or more reading devices 62,and the unique shipment identifier is stored in the medical facilityinventory database 52 in association with a unique personnel identifier65 of the person responsible for receiving the shipment of medical itemsat the medical facility. In preferred embodiments, the one or morereading devices 62 may include one or more RFID tag readers and theirassociated antennas and one or more bar code readers. The one or morereading devices 62 may also read the unique personnel identifier 65 ofthe person responsible for receiving the shipment of medical items atthe medical facility, which identifier may be encoded in the person's IDbadge 63.

Upon unpacking a received shipment 54 of medical items and placementinto storage bins 70 in a supply room 68 at the medical facility (thirdtransition point), the unique shipment identifier 58 and the unique itemidentifier 39 on each medical item 38 is read and decoded by one or morereading devices 66, and the unique item identifier 39 of each medicalitem 38 is stored in association with a unique supply room identifier inthe inventory database 52 for the medical facility. In preferredembodiments, the one or more reading devices 66 may include one or moreRFID tag readers and their associated antennas and one or more bar codereaders. In preferred embodiments, the inventory database 52 alsocross-references the unique item identifiers 39 with a unique personnelidentifier 69 of the person responsible for placement of the medicalitems into inventory at the medical facility, which identifier may beencoded in the person's ID badge 67.

As shown in FIG. 24, upon pulling medical items 38 from the supply roomstorage bins 70 to be used in a medical procedure, examination or test,or to be otherwise dispensed to a patient (fourth transition point), theunique item identifier 39 on each medical item 38 is read and decoded bya portal reading device 41 in the supply room, and the unique itemidentifier of each medical item is stored in the inventory database 52in association with a unique bill of material (BOM) identifier 73 of theBOM 74 for the procedure/exam/test. In a preferred embodiment, theunique item identifiers 39 and BOM identifier 73 is cross-referenced inthe database 52 with a unique personnel identifier 75 of the personremoving the medical items from the supply room, which identifier may beencoded in the person's ID badge 71. At this point, the medical itemsmay be in a transport bin 34.

Upon delivery of the medical items 38 to a procedure room, examinationroom, or test room in the medical facility (fifth transition point), theunique item identifier 39 on each medical item is read and decoded by aportal reading device 48 in or at the entrance to theprocedure/exam/test room, and the unique item identifier of each medicalitem is stored in the inventory database 52 in association with a uniqueprocedure/exam/test room identifier and a unique personnel identifier 49of a person accepting delivery in the procedure/exam/test room. Theunique personnel identifier 49 may be encoded in the person's ID badge47.

As shown in FIG. 25, upon dispensing the medical items 38 to a patientor otherwise consuming the medical items during a procedure or testperformed on the patient in the procedure/exam/test room (sixthtransition point), the unique item identifier 39 on the packaging 20 ofeach used medical item is read and decoded by a reading device 28associated with the waste bin 18 in the supply room, and the unique itemidentifier of each medical item is stored in the inventory database 52in association with a unique patient identifier.

The medical items 38 that are not used or consumed during the medicalprocedure are preferably placed back into the transport bin 34, thetransport bin 34 is passed through the portal 48, and the reader 46reads the RFID tags of the unused items 38. In a preferred embodiment,the item identification information encoded in those RFID tags iscross-referenced in the database 52 with a unique personnel identifierof the person removing the unused medical items from the medicalprocedure room and transporting the items to the supply room forrestocking, which identifier may be encoded in the person's ID badge.

At each transition point, a prompt may be automatically generated toremind the responsible personnel to scan the unique item identifier 39on each medical item 38 so that the information will be entered into theinventory database 52, or to remind the responsible personnel to takeother action as may be necessary based on the location and status of themedical items 38. These prompts may be visual or audible.

In this preferred embodiment, the inventory database 52 maintains achain of custody for each item 38 through each transition point (and foreach shipment 54 of items between the first and second transitionpoints) and keeps records of the personnel responsible for each item orshipment at each location at any particular time.

At some transition points, individual medical item information may notbe specifically recorded, although bulk information associated with thepacking list 56 will be recorded. When the medical items are dispensedto the subsequent transition point, the unique item identifiers 39 mayrecovered and the unique item identifier information can beautomatically associated with the dispensing activity where unique itemidentifier information was previously not recorded.

Although a particular sequence of transition points is described,transition points could consist of any handling point along the supplychain for a medical item from manufacturer to patient.

In further embodiments, each transition point is defined by the type oflocation. Each type of location may have a set of characteristicsassociated with that location type that trigger certain action promptswhen the medical items are associated with that particular location typein the database 52. For example, when the shipment 54 of medical itemsis received at a supply room 68, such as by scanning the identificationinformation on a packing list 56, the supply room identificationequipment may prompt the inventory management personnel to place theproducts in the appropriate product storage location, initiate an RFIDscan of the room to identify the medical items present in the room andsubsequently present information to the inventory management personnelto determine if the room inventory, as updated, reconciles with thepacking list.

In another example, when the RFID reader 48 in a procedure/examinationroom detects in the room a medical item that is considered to be DurableMedical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS, alsocollectively referred to herein simply as “DME”), and it also detects apatient identification number encoded in an RFID tag associated with aparticular patient in the room, the procedure room computer 30 maygenerate action prompts based on association of the DME item with thepatent. For example, the procedure room computer 30 may prompt thetreating personnel to disclose to the patient certain informationrelated to the proper use of the DME item, to input information toverify the delivery of the DME item to the patient, or to obtain thepatient's signature to acknowledge receipt of the DME item. In asituation in which an old or used DME item is detected in the room, andthe patient is supposed to receive a new item, the system may generate anotification to treating personnel that the old/used item should go backto hospital stock and a new item should be dispensed to patient.

In some embodiments, the exits of the hospital or other medical facilityare transition points at which networked RFID tag readers arepositioned. When a just-dispensed DME item is detected at any of theseexit transition points, the medical item inventory computer 31 triggersa billing change event to cause the billing for the DME item to changefrom Medicare Part A, in which the medical facility pays for rental, toMedicare Part B, in which the patient or the patient's insurance companyis billed for the item. This exit event may also cause the medical iteminventory computer 31 to update the chain of custody for the DME item toindicate a transfer of possession from the medical facility to thepatient. Such an exit event may also trigger the sending ofnotifications to the patient and medical personnel regarding follow-upcare for patient using the DME item, such as notifications recommendinga Part B healthcare provider and prompting the scheduling of follow-upappointments.

Medical Item Supply Room

FIG. 26 depicts a functional block diagram of features of a medical itemsupply room 68 according to a preferred embodiment. Within the supplyroom 68 are one or more storage bins 70 in which medical items 38 arestored until they are needed for treatment of a patient. As the term isused herein, a “storage bin” is any storage structure in or on whichmedical items may be stored, including but not limited to a container,shelf, drawer, hanger, or cabinet. One or more RFID antennas 72 aredirected toward the storage bins 70 to detect RFID tags on medical items38 stored therein. The antennas 72 are electrically connected to one ormore RFID tag readers 66 that are in communication with the medicalfacility network 42. In some embodiments, a supply room computer 64 isprovided to allow personnel in the supply room 68 to access medical iteminventory information over the network 64.

In some embodiments, the supply room 68 has RF shielding 76 in thewalls, floor and ceiling to prevent detection of RFID tags that areoutside the supply room. RFID shielding 76 may also be provided ingaskets around the edges of the door frame and in a door sweep on thebottom of the door.

In some embodiments, a computer 78 is built into the door 74 of themedical item supply room 68. As shown in FIG. 27, this computer 78preferably includes a processor 80, a touch screen display 82, keypad84, biometric sensor 86 such as a fingerprint reader or retinal scanner,and a code reader 90, such as an RFID reader, barcode reader or magneticstripe reader, for reading identification information of personnelseeking access to the supply room and decoding the unique personnelidentifiers encoded personnel ID badges. In a preferred embodiment, theprocessor 80 interfaces with one or more sensors 85 that sense whetherthe door 74 is in an open state or a closed state and/or whether thedoor is locked or unlocked.

The computer 78 may also interface with a door lock controller 88 toallow or deny access to the room based on the identity of the personseeking access and based on ongoing activities in the room. For example,if another person is in the room entering items into inventory, thecomputer may be programmed to not allow access so as not allow outsideRFID signals into the room and interfere with the ongoing inventoryactivity. The computer 78 may also be programmed to keep the door lockedwhile an RFID scan is taking place, whether or not anyone is in theroom. The computer 78 may also be programmed to deactivate the RFIDreader 66 inside the room when the door is open so that no RFID tags onitems outside the room will be detected.

In some embodiments, the supply room computer 64 or the computer 78controls the RFID tag reader(s) 66 to perform an RFID antennacalibration procedure. This procedure may involve placing a known numberof RFID-tagged items in various different storage bins 70 in the supplyroom 68 with the RFID tag reader 66 initially deactivated. The computer64 then activates the RFID tag reader 66 at a first relatively lowtransmitter power level and the number of tags detected is noted. If notall the tags present in the room were detected, the transmitter powerlevel is increased by a small amount to a second power level that isgreater than the first power level and the number of tags detected isnoted. This procedure is repeated until all tags are detected, and thelowest transmitter power level at which all tags were detected is storedas the optimum operational level. This general procedure could also beperformed by starting at a relatively high transmitter power level atwhich all tags are detected and then stepping down in power until notall of the tags are detected.

The foregoing description of preferred embodiments for this inventionhave been presented for purposes of illustration and description. Theyare not intended to be exhaustive or to limit the invention to theprecise form disclosed. Obvious modifications or variations are possiblein light of the above teachings. The embodiments are chosen anddescribed in an effort to provide the best illustrations of theprinciples of the invention and its practical application, and tothereby enable one of ordinary skill in the art to utilize the inventionin various embodiments and with various modifications as are suited tothe particular use contemplated. All such modifications and variationsare within the scope of the invention as determined by the appendedclaims when interpreted in accordance with the breadth to which they arefairly, legally, and equitably entitled.

What is claimed is:
 1. An apparatus for tracking custody of medicalitems in a supply and consumption chain, wherein each medical item hasan RFID tag attached thereto that encodes medical item informationspecific to the medical item, wherein the medical items are initiallycollected together as a shipment of medical items, and wherein theshipment has a packing list associated therewith and the packing listhas a shipment identifier associated therewith that encodes shipmentidentification information specific to the shipment, the apparatuscomprising: a first reading device disposed in an area of a medicalfacility at which the shipment of the medical items is received, thefirst reading device for reading the shipment identifier associated withthe packing list and decoding the shipment identification informationencoded in the shipment identifier; one or more first RFID antennasdisposed in a supply room in the medical facility, the one or more firstRFID antennas for receiving first radio frequency signals emanated fromthe RFID tags attached to the medical items in the shipment after themedical items have been brought into the supply room, wherein the firstradio frequency signals contain the medical item information encoded inthe RFID tags attached to the medical items; one or more first RFIDreaders associated with the supply room of the medical facility andelectrically connected to the one or more first RFID antennas, the oneor more first RFID readers for decoding the medical item informationcontained in the first radio frequency signals emanated from the RFIDtags attached to the medical items; a second reading device associatedwith the supply room of the medical facility, the second reading devicefor reading at least the shipment identifier associated with the packinglist and decoding the shipment identification information encoded in theshipment identifier; a medical facility inventory computer in electricalcommunication with the first reading device, the one or more first RFIDreaders, and the second reading device, the medical facility inventorycomputer programmed to receive the shipment identification information,the medical item information, a first personnel identifier thatidentifies a person responsible for receiving the shipment of medicalitems at the medical facility, a second personnel identifier thatidentifies a person responsible for placement of the medical items intoinventory at the medical facility, and a supply room identifier thatidentifies the supply room into which the medical items are placed intoinventory; and a medical item inventory database in electricalcommunication with the medical facility inventory computer, the medicalitem inventory database for associating at least the shipmentidentification information with the first personnel identifier, thesecond personnel identifier, and the supply room identifier, wherein themedical facility inventory computer is programmed to automaticallygenerate one or both of a first message directed to the personresponsible for receiving the shipment of medical items at the medicalfacility and a second message directed to the person responsible forplacement of the medical items into inventory at the medical facility,the generation of the first message triggered by the shipmentidentification information becoming associated with the first personnelidentifier, and the second message triggered by the shipmentidentification information becoming associated with the second personnelidentifier, wherein the first and second messages prompt the person towhom they are directed to take some action with regard to the shipmentof medical items.
 2. The apparatus of claim 1 wherein the shipmentidentifier comprises an RFID tag attached to the packing list, andwherein the first reading device comprises an RFID reader.
 3. Theapparatus of claim 2 wherein the second reading device comprises one ofthe one or more first RFID readers associated with the supply room. 4.The apparatus of claim 1 wherein the medical facility inventory computeris operable to automatically associate the supply room identifier withthe medical item information of the medical items in the shipment,wherein the association is triggered by the RFID tags on the medicalitems in the shipment being detected by the one or more first RFIDreaders or the shipment identifier being read by the second readingdevice.
 5. The apparatus of claim 1 wherein the medical item inventorydatabase maintains a chain of custody of the medical items in theshipment based on cross-referencing the shipment identificationinformation with the first personnel identifier and the second personnelidentifier.
 6. The apparatus of claim 1 further comprising: a supplyroom portal having: a portal opening; and one or more second RFIDantennas having fields of view directed to the portal opening, the oneor more second RFID antennas for receiving second radio frequencysignals emanated from RFID tags attached to medical items that passthrough the portal based on the medical items being picked for removalfrom the supply room to be used in a medical procedure; and a secondRFID reader electrically connected to the one or more second RFIDantennas of the supply room portal, the second RFID reader for decodingthe medical item information contained in the second radio frequencysignals emanated from the RFID tags; the medical facility inventorycomputer being programmed to automatically associate a third personnelidentifier with the medical item information contained in the secondradio frequency signals, wherein the association is triggered by theRFID tags on the medical items in the shipment being detected by thesecond RFID reader, and wherein the third personnel identifieridentifies a person responsible for removal of the medical items fromthe supply room.
 7. The apparatus of claim 6 wherein the medical iteminventory database maintains a chain of custody of the medical items inthe shipment based on cross-referencing the medical item informationcontained in the second radio frequency signals with the third personnelidentifier.
 8. The apparatus of claim 6 wherein the medical facilityinventory computer is operable to automatically generate a third messagedirected to the person responsible for removal of the medical items fromthe supply room, the generation of the third message triggered by themedical item information contained in the second radio frequency signalsbecoming associated with the third personnel identifier, wherein thethird message prompts the person to whom it is directed to take someaction with regard to the medical items that have been removed or are tobe removed from the supply room.
 9. The apparatus of claim 1 furthercomprising: a procedure room portal having: a portal opening; and one ormore third RFID antennas having fields of view directed to the portalopening, the one or more third RFID antennas for receiving third radiofrequency signals emanated from RFID tags attached to medical items thatpass through the procedure room portal when the medical items arebrought into a medical procedure room to be used in a medical procedure;and a third RFID reader electrically connected to the one or more thirdRFID antennas of the procedure room portal, the third RFID reader fordecoding the medical item information contained in the third radiofrequency signals emanated from the RFID tags; the medical facilityinventory computer being programmed to automatically associate a fourthpersonnel identifier with the medical item information contained in thethird radio frequency signals, wherein the association is triggered bythe RFID tags on the medical items in the shipment being detected by thethird RFID reader, and wherein the fourth personnel identifieridentifies a person responsible for the medical items while the medicalitems are in the medical procedure room.
 10. The apparatus of claim 9wherein the medical item inventory database maintains a chain of custodyof the medical items in the shipment based on cross-referencing themedical item information contained in the third radio frequency signalswith the fourth personnel identifier.
 11. The apparatus of claim 9wherein the medical facility inventory computer is operable toautomatically generate a fourth message directed to the personresponsible for the medical items while the medical items are in themedical procedure room, the generation of the fourth message triggeredby the medical item information contained in the third radio frequencysignals becoming associated with the fourth personnel identifier,wherein the fourth message prompts the person to whom it is directed totake some action with regard to the medical items brought into themedical procedure room.
 12. The apparatus of claim 9 further comprising:a shielded enclosure disposed in the medical procedure room, theshielded enclosure having an internal space for receiving wrappers ofmedical items used during the medical procedure, the shielded enclosureconfigured to attenuate radio frequency signals emanated from RFID tagsdisposed outside the shielded enclosure to levels that are substantiallyundetectable within the internal space; one or more fourth RFID antennasdisposed within the internal space of the shielded enclosure, the one ormore fourth RFID antennas for receiving fourth radio frequency signalsemanated from RFID tags attached to the wrappers disposed within theinternal space, wherein the fourth radio frequency signals contain themedical item information encoded in the RFID tags; at least one fourthRFID reader electrically connected to the one or more fourth RFIDantennas, the at least one fourth RFID reader for decoding the medicalitem information contained in the fourth radio frequency signalsemanated from the RFID tags attached to the wrappers disposed within theinternal space; and the medical facility inventory computer beingprogrammed to automatically associate a patient identifier with themedical item information contained in the fourth radio frequencysignals, wherein the association is triggered by the RFID tags of themedical items in the shipment being detected by the fourth RFID reader,and wherein the patient identifier identifies a patient on which themedical procedure was performed in the medical procedure room.
 13. Theapparatus of claim 12 wherein the medical item inventory databasemaintains a chain of custody of the medical items in the shipment basedon cross-referencing the medical item information contained in thefourth radio frequency signals with the patient identifier.
 14. Theapparatus of claim 12, wherein the medical facility inventory computeris programmed to automatically generate a fifth message directed topatient treatment personnel if the medical item information indicatesthat the medical item is a DME item, the generation of the fifth messagetriggered by the medical item information contained in the fourth radiofrequency signals becoming associated with the patient identifier,wherein the fifth message prompts patient treatment personnel to performone or more of the following actions: disclose information to thepatient related to the proper use of a DME medical item; inputinformation to verify delivery of a DME medical item to the patient; andobtain the patient's signature to acknowledge receipt of a DME medicalitem.
 15. An apparatus for maintaining an inventory of medical items ina medical facility, wherein each medical item has an RFID tag attachedthereto that encodes medical item information specific to the medicalitem, the apparatus comprising: a shielded enclosure comprising shieldedwalls, a shielded floor, and a shielded ceiling that collectively definean internal space for storing the medical items; a shielded doordisposed in one of the shielded walls of the shielded enclosure, theshielded door operable to allow personnel to enter and exit the internalspace; a door lock controller for electronically controlling a lock onthe shielded door; one or more sensors associated with the shielded doorfor sensing an open state or closed state of the shielded door; one ormore storage bins disposed in the internal space, each storage bin forholding one or more medical items; one or more RFID antennas disposed inthe internal space and adjacent the one or more storage bins, the one ormore RFID antennas for receiving radio frequency signals emanated fromthe RFID tags attached to the medical items in the storage bins, whereinthe radio frequency signals contain the medical item information encodedin the RFID tags attached to the medical items; one or more RFID readerselectrically connected to the one or more RFID antennas, the one or moreRFID readers for performing scans to detect RFID tags within range ofthe one or more RFID antennas and decoding the medical item informationcontained in the radio frequency signals emanated from detected RFIDtags; a computer in electrical communication with the one or more RFIDreaders and the one or more sensors associated with the shielded door,the computer programmed to discontinue scans by the one or more RFIDreaders to detect RFID tags if signals from the one or more sensorsassociated with the shielded door indicate that the shielded door is inan open state, thereby preventing the one or more RFID readers fromdetecting RFID tags that are outside the shielded enclosure.
 16. Theapparatus of claim 15 wherein the computer is in electricalcommunication with the door lock controller and is programmed to causethe door lock controller to maintain the shielded door in a locked statewhile the one or more RFID readers are performing a scan to detect RFIDtags.
 17. The apparatus of claim 15 wherein the computer is disposedwithin the shielded door.
 18. The apparatus of claim 15 wherein thecomputer is in electrical communication with one or more code readersdisposed on or adjacent the shielded door, the one or more code readersoperable to read and decode identification information on anidentification device carried by personnel seeking access to theshielded enclosure, and the computer is programmed to control the doorlock controller to lock or unlock the door based on the identificationinformation.
 19. The apparatus of claim 15 wherein the computer is inelectrical communication with one or more biometric sensors for sensingbiometric information indicating the identity of personnel seekingaccess to the shielded enclosure, and the computer is programmed tocontrol the door lock controller to lock or unlock the door based on theidentity.
 20. The apparatus of claim 15 wherein the computer isprogrammed to control the one or more RFID readers to perform an RFIDsystem calibration procedure involving a known number of RFID tagsattached to medical items disposed in the shielded enclosure, theprocedure comprising: (a) performing a scan of the RFID tags with theone or more RFID readers set at a first transmitter power level; (b) theone or more RFID readers detecting a first number of RFID tags attachedto the medical items disposed in the shielded enclosure; (c) comparingthe first number of RFID tags to the known number of RFID tags; (d) ifthe first number of RFID tags is less than the known number of RFIDtags, performing a scan of the RFID tags with the one or more RFIDreaders set at a second transmitter power level that is incrementallyhigher than the first transmitter power level; (e) repeating steps (b)through (d) until the first number of RFID tags equals the known numberof RFID tags; and (f) operating the one or more RFID readers at thesecond transmitter power level for ongoing inventory maintenancepurposes.
 21. The apparatus of claim 15 wherein the computer isprogrammed to control the one or more RFID readers to perform an RFIDsystem calibration procedure involving a known number of RFID tagsattached to medical items disposed in the shielded enclosure, theprocedure comprising: (a) performing a scan of the RFID tags with theone or more RFID readers set at a first receiver sensitivity level; (b)the one or more RFID readers detecting a first number of RFID tagsattached to the medical items disposed in the shielded enclosure; (c)comparing the first number of RFID tags to the known number of RFIDtags; (d) if the first number of RFID tags is less than the known numberof RFID tags, performing a scan of the RFID tags with the one or moreRFID readers set at a second receiver sensitivity level that isincrementally higher than the first receiver sensitivity level; (e)repeating steps (b) through (d) until the first number of RFID tagsequals the known number of RFID tags; and (f) operating the one or moreRFID readers at the second receiver sensitivity level for ongoinginventory maintenance purposes.